FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122857–122880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1991
E. COLI 0157 LATEX TEST
K903714 · GNA
Pro-Lab, Inc.
Microbiology · 163d
Cleared Jan 24, 1991
DENSICOMP 250
K904587 · KPW
L. Keroack Co.
Radiology · 107d
Cleared Jan 24, 1991
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K904907 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 85d
Cleared Jan 24, 1991
LIATEST(R) AT III TEST KIT
K905110 · JBQ
American Bioproducts Co.
Hematology · 72d
Cleared Jan 24, 1991
VISTA HPQ SYSTEM
K905259 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Jan 24, 1991
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
K905574 · FGD
E-Z-Em, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 24, 1991
HYPOALLERGENIC LATEX EXAMINATION GLOVES
K910009 · LYY
Straitscom
General Hospital · 22d
Cleared Jan 24, 1991
PARK CITY SHOULDER POSITIONER
K910031 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 20d
Cleared Jan 23, 1991
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR
K903104 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 194d
Cleared Jan 23, 1991
BML SERIES
K903529 · LQC
Olympus Corp.
Gastroenterology & Urology · 170d
Cleared Jan 23, 1991
CONDOM SEAL
K903715 · EXJ
Mark Sullivan, M.D., P.C.
Gastroenterology & Urology · 162d
Cleared Jan 23, 1991
ST-E1 OVERTUBE
K903842 · FED
Olympus Corp.
Gastroenterology & Urology · 155d
Cleared Jan 23, 1991
SEROZYME CORTISOL TEST KIT
K903975 · CGR
Serono-Baker Diagnostics, Inc.
Chemistry · 148d
Cleared Jan 23, 1991
JMB TRADING COMPANY SUNGLASSES
K904161 · HQY
Jmb Trading Co.
Ophthalmic · 134d
Cleared Jan 23, 1991
FLUOROSCOPIC TABLE, TILT OR POWER TILTING MED. TAB
K904722
Tri W-G, Inc.
Radiology · 97d
Cleared Jan 23, 1991
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
K904989 · JJY
Creative Laboratory Products, Inc.
Chemistry · 77d
Cleared Jan 23, 1991
FLEXIBLE INTRACARDIAC SUCTION DEVICE
K905008 · DTS
Gish Biomedical, Inc.
Cardiovascular · 78d
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261 · CDP
Abbott Laboratories
Chemistry · 63d
Cleared Jan 23, 1991
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K905265 · IXR
Tri W-G, Inc.
Radiology · 61d
Cleared Jan 23, 1991
STORZ S6000 LIGHT SOURCE
K905376 · FCW
Storz Instrument Co.
Gastroenterology & Urology · 54d
Cleared Jan 23, 1991
TOPICAL COOLING PAD, MODEL 7000
K905568 · DTR
Daily Medical Products, Inc.
Cardiovascular · 42d
Cleared Jan 23, 1991
FLAGEN TRIIODOTHYRONINE (T3) ASSAY
K905656 · CDP
Cyberfluor, Inc.
Chemistry · 37d
Cleared Jan 23, 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762 · JJQ
Gen-Probe, Inc.
Chemistry · 27d
Cleared Jan 23, 1991
SURE GRIP, HAND CONTROLS MODEL SG-1
K910072 · IPQ
Howell Ventures , Ltd.
Physical Medicine · 14d